One-year Clinical Performance Of Novel Self-adhesive Restorative vs. Conventional Bulk-fill-composite

Objectives: In the context of the phase-down of amalgam, development of easily applicable, permanent restorative materials is of high clinical interest. Aim of this study was to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative (SABF, 3M) and a conventional bulk-fill composite (Filtek One, 3M; FOBF) for restoring class-II cavities. The null-hypothesis tested was that both materials perform similar regarding clinical quality and survival.
Methods: In this randomized split-mouth study, 30 patients received one SABF and one FOBF restoration each. Scotchbond Universal (3M) was used as adhesive for FOBF (self-etch mode), while SABF was applied directly without adhesive. Restorations were evaluated by two blinded examiners at baseline (BL), 6- and 12-months employing FDI criteria. Non-parametric statistical analyses, χ²-tests (α=0.05) and error-rates method were applied.

Results: 30 patients (21-58 years; 21 females) with both restorations under risk were available for the 6- and 12-month recalls exhibiting 100% restoration-survival. All restorations revealed clinically acceptable FDI scores (excellent-1; good-2; satisfactory-3) at all timepoints and for all criteria. Error-rates method revealed no significant differences between materials in general in terms of functional and biological properties. Regarding esthetic properties, both materials yielded clinically acceptable FDI scores only (mainly excellent-1 and good-2), with FOBF performing significantly better than SABF in criteria surface lustre (A1) and color match and translucency (A3) at all time points and marginal staining (A2b) at 12-months. Criterion patient’s view (B10) indicated that all patients were fully satisfied with their restorations.

Conclusions: The null-hypothesis could not be rejected. Both materials performed similarly regarding survival and clinical performance within the first year of clinical service. SABF exhibited slightly inferior, but clinically fully acceptable esthetic properties compared to FOBF. Consequently, within the limitations of this study, the novel, self-adhesive bulk-fill restorative showed promising results and may be recommended for clinical use.